SEDECAL SA 2024-02-21 Health serious FDA
Health · FDA · Recall #FDA-Z-1083-2024
MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007 Recall
Issued February 21, 2024 · SEDECAL SA
In February 2024, SEDECAL SA recalled the MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine positioning control button. This would result in the system moving on its own in a very slow speed forward circular motion.
What you should do
- 1 Stop using MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact SEDECAL SA to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- SEDECAL SA
- Category
- Health
- Recall date
- February 21, 2024
- Units affected
- Not reported
- Sold at
- US Nationwide distribution. There was government distribution but no military distribution.
- Recall number
- FDA-Z-1083-2024
- Made in
- Spain
- Issuing agency
- FDA
In context
- SEDECAL SA has 5 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.